Effective treatment of many common illnesses and medical conditions requires the administration of medications in a planned and controlled manner. Typically, a physician may prescribe a course of treatment for a patient. The patient is then responsible for taking the prescribed medication according to the instructions of the physician. Compliance with the prescribed medication at the proper times and dosages is often key to successful treatment and management of the associated illness or medical condition but all too often, patients either forget or elect not to follow the regimen prescribed. Research indicates that 40% of medications are not taken as prescribed. Moreover, many studies have shown that patients routinely simply fail to comply with the physician's directives and that compliance drops off precipitously when multiple medications or dosing schedules are prescribed.
For example, a physician may prescribe multiple medications aimed at treating different aspects of an illness or multiple medical conditions such as hypertension and hypercholesterolemia. As the number of medications prescribed increases, the responsibility on the part of the patient increases because of different dosages, intervals between dosages, and the like. Noncompliance is especially problematic when the medical condition being treated is chronic and extended therapeutic regimens are prescribed, often requiring therapeutic changes based on clinical symptoms. However, research has determined that neither the severity of the illness being treated nor the potentially life-threatening consequences related to the patient's failure to follow the course of treatment prescribed by the treating physician significantly improve compliance.
Another problem that has been experienced by prescription drug users is the overall safety of a patient's medications, including interactions between medications and/or special requirements that must be met when taking medications. For example, a physician may indicate that the prescribed medications must be taken in a certain order in order to maximize their efficiency with respect to treating specific medical conditions. In other cases, additional medical specialists may recommend that selected medications be taken with food or water. Further still, other medications may be prescribed to be taken in the absence of alcohol, other intoxicants or medications and even certain foods, such as grapefruit. All of the directions and warnings must be observed by the patient so that the course of treatment will be safe and effective.
Research has also shown that prescription drug users often do not fully understand the impact of failing to comply with the instructions provided by the physician and/or the pharmacist. Many patients either forget to take a specific medication at all or otherwise simply fail to observe the warnings described above.
Several factors appear to affect a patient's compliance with a prescribed course of treatment. These factors include (1) the accessibility of the medication at the prescribed time, (2) the forgetfulness of the patient, typically associated with age or temporarily induced by the type of medications such as opioid pain treatment medicines, (3) the accountability of the patient to a person who is aware of the treatment prescribed and who may monitor the compliance of the patient, (4) the complexity and frequency of medication dosages and (5) prolonged use of the prescribed medication. Other factors such as changes in physical environment of the patient, the ease by which certain medications can be retrieved from their dispensers and/or the diminution of symptoms produced by the effectiveness of the medication may also affect patient compliance.
Patient's noncompliance with a prescribed regimen can lead to several problems. Most obviously, the desired effect of treatment may not be obtained. Secondly, when missing a dose, a patient may attempt to rectify the situation by taking an additional dose. However, a dose taken at the incorrect time and interval could have severe consequences for some drugs. In addition, irregular drug administration could lead to drug resistance, particularly in the case of treating bacterial infections with antibiotics. In addition, a physicians may make changes in medications based on a persons symptoms which are a result of non compliance.
Patients all too often rely on memory and/or on manually operated medication dispensers to manage their treatment and their compliance with the instructions provided by the physician. For example, patients may rely on daily dosage pillboxes or similar devices to remind them to take their medication on a daily basis. However, these devices do not generally include any means for determining proper dosage intervals, especially for medications that must be taken more than once a day. Most of these devices do not provide any means for alerting a patient to the proper time and/or day for taking the prescribed medication, nor do these devices provide any means for reporting patient compliance to a medical professional or other trusted party. Moreover, none of these devices provide a mechanism for simultaneously remotely monitoring vital signs such as blood pressure, weight, and pulse for the particular medical condition being treated. For example, if the blood pressure is higher than desired and the patient is not taking their medications as prescribed, the physician can reiterate the need to be compliant with the medication instructions before making any changes in medication or other therapeutic suggestions.
Several efforts have been made to produce a device or method to help improve patient compliance with treatment regimens. For example, U.S. Pat. No. 6,529,446 and U.S. Pat. No. 6,259,654 to de la Huerga discloses a medication organizer with multiple vials secured to a unitary lid. Prescription and medication information is stored in a memory chip attached to the vial, which can be detected by the sensors in the unitary lid. The microprocessor determines the time of medication and reminds the patient with audible and visual alerts and a display, and the compliance information can be stored and communicated remotely. The device requires preparation of separate vials with individual memory chips each time a drug is dispensed by a pharmacist.
U.S. Pat. No. 6,560,165 to Barker discloses a medical information appliance in the form of a wrist watch which reminds a user of times to take medications or to perform medical-related activities. It features a delay mode, which shuts the alarm off but later reminds the user to take the indicated medication. Multiple alarms can be set for a variety of medications or other medical events, and multiple delay modes will be activated, so that the user is reminded to take medications which have been indicated by an alarm, but taking the medication was not confirmed by the user. The device also features a readout button for displaying stored medical information, for use by medical technicians in the field without connection to further equipment.
U.S. Pat. No. 4,293,845 to Villa-Real discloses a pocket-size electronic multi-patient medication-time-intake programmer and alarm system for use in homes, offices, clinics and hospitals in order to properly program a plurality of patients taking a singular or a plurality of medications, respectively, based on the desired time interval or frequency in hours as well as the duration in days. The device includes a memory in which all the program data during the certain time frame becomes stored and utilized to trigger the alarm system of the device to give the patient or the individual taking care of the patient or patients, the correct indication of the patient identification and the medicine identity to be taken at the particular instant when the alarm sounds. The device is also capable of registering the actual time and actual date of the dispensed medication.
U.S. Pat. No. 5,710,551 to Ridgeway, discloses a system for the remote monitoring of in-home self-medication to assure compliance with prescribed dosage schedules. The system comprises at least one patient home medication station which interfaces with a communications link and a remote central monitoring station also interfaced with the link and operative to receive and analyze messages transmitted by the home medication station. A central station computer means verify receipt of such signals within each subscriber's uniquely scheduled dosage time windows, and alerts an operator to take appropriate action if a dosage schedule error is detected. Since the central station will be alerted if any scheduled dosage is missed, no emergency rendering a patient unable to press a help-button or call for help can go undetected longer than the maximum time between consecutively scheduled dosages.
Canadian Patent Application No. 2,251,234 to Girgis discloses a portable medication reminder and compliance device. The disclosed device contains several medication compartments with a single LCD display providing medication information and messages, and alerting patients at medication times. The compliance data can be stored and communicated remotely. However, the medication compartments either contain no lid or just a simple cover with no control mechanism. Furthermore, the alert signals must be manually silenced in order to be recorded as an event of compliance.
U.S. Pat. No. 5,850,937 to Rauche discloses a pill dispenser with means to alert users of the time of medication, and the medication compartments are organized by each day of week or each day of month. The device requires input of a personal identification number or PIN for each user at each medication time, and the access of pills requires matching of correct PIN at each of the medication time.
Canadian Patent Application No. 2,212,086 to Ho et al. discloses a medication storage device with the compartments organized in each day of month, and a separate reminder unit providing visual and vibration alerts.
A pill organizer as disclosed in UK Patent No. GB 2,344194 to Doughty discloses medication compartments organized by multiple periods in a day for 8 days. In one embodiment, the compartments are sealed by film and the puncture of film is recorded as an event of medication compliance.
U.S. Pat. No. 4,617,557 to R. E. Gordon discloses a device specially designed for use with a blister package, having alert mechanism. The display is significantly abbreviated due to a limited display area. It reminds the user of the medication time by displaying time to next dose. The blister package needs to be specially prepared for each medication, and a patient may require multiple sets for multiple medications.
U.S. Pat. No. 6,198,383 issued on Mar. 6, 2001 to Sekura et al. discloses a small medication compliance device for single or multiple medications. The device reminds a user of the time to take medication, and it contains an event switch activated by a user after taking medication. The device is small enough to be attached to medication compartments which are physically separate, and the device further includes a remote programming feature via a wireless link.
It will be appreciated that medication compliance is critical to ensure that patients receive the maximum benefit of a prescribed course of treatment by their physician. In addition, no easy solution exists to combine taking a medication with a patient's body's response (i.e. vital signs) to the medication so that physicians and patients know whether or how the medication is/is not working. Lastly, as patients are more frequently taking a number of medications each with different frequencies and durations, it will be appreciated that a medication reminder system that is more sophisticated than a simple reminder is needed.
Despite previous efforts in the area of medical compliance devices, many of the devices heretofore reported are either cumbersome (e.g., the devices are not portable), expensive, lack desired functionality, or require complicated procedures for programming. Moreover, many prior devices and methods are complicated and difficult to use, especially for patients having compromised physical and/or cognitive abilities.
Currently the two tasks of managing medications and managing chronic conditions have been addressed in individual devices targeted to single components, typically, simply reminding a person to take a medication, such as measuring a vital sign and then reporting the results of both through independent communication to separate servers—vital signs or reports of taking medications. Some devices are PC based, some are mobile phone based, and many others require manual data entry, etc.
Currently no known medication dispensing device bridges the gap on mutually managing vitals and compliance in an easy to use consumer interface.
There is, therefore, a need for a simple but effective device that will assist a patient in managing their intake of prescription or over-the-counter medications and compliance with prescribed regimens. There is also a need for a mechanism to easily integrate remote monitoring devices and procedures for monitoring medical vital sign data and medication compliance in patients and for methods of reporting monitored vital sign data and compliance to a remote or centralized monitoring station where the information can be reported in real-time and/or stored for later retrieval.